Prediction of Difficult Mask Ventilation Using 3D-Facescan and Machine Learning

General Anesthesia Clinical Trial

— MASCAN  

Official title:

Proof-of-principle Study for the Prediction of Difficult Mask Ventilation Using 3D-Facescan and Machine Learning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05411406
• Other study ID #: 2022-100811-BO-ff
• Status: Completed
• Start date: November 7, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: September 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to prove feasibility and assess the diagnostic performance of a machine learning algorithm that relies on data from 3D-face scans with predefined motion-sequences and scenes (MASCAN algorithm), together with patient-specific meta-data for the prediction of difficult mask ventilation. A secondary aim of the study is to verify whether voice and breathing scans improve the performance of the algorithm. From the clinical point of view, we believe that an automated assessment would be beneficial, as it preserves time and health-care resources while acting observer-independent, thus providing a rational, reproducible risk estimation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 423
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduling for ENT or OMS surgery in general anaesthesia, who require facemask ventilation and tracheal intubation after induction of anesthesia

• Patients aged at least 18 years

• Ability to understand the patient information and to personally sign and date the informed consent to participate in the study

• The patient is co-operative and available for the entire study

• Provided informed consent/patient representative

Exclusion Criteria:

• Pregnant or breastfeeding woman

• Rapid sequence induction or other contraindications for facemask ventilation

• Planned awake tracheal intubation

Related Conditions & MeSH terms

• General Anesthesia
• Mask Ventilation

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Institute of Medical Technology and Intelligent Systems at Hamburg University of Technology

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difficult facemask ventilation	Observed difficult facemask ventilation after induction of anesthesia	1 hour
Secondary	Difficult tracheal intubation	Observed difficult intubation after induction of anesthesia	1 hour
Secondary	Difficult laryngoscopy	Observed difficult laryngoscopy after induction of anesthesia	1 hour
Secondary	Number of attempts	Observed during tracheal intubation	1 hour
Secondary	Failed direct laryngoscopy	Observed during airwaymanagement	1 hour
Secondary	Cormack Lehane grade	Grading of the best view obtained during laryngoscopy (I-IV)	1 hour
Secondary	Difficult mask ventilation alert	Noted by the responsible anaesthesiologist after airway management	1 hour
Secondary	Difficult intubation alert	Noted by the responsible anaesthesiologist after airway management	1 hour
Secondary	Intubation time	Recorded during airwaymanagement	1 hour
Secondary	Time to sufficient mask ventilation	Recorded during airwaymanagement	1 hour
Secondary	Classification of intubation difficulty	VIDIAC score rating between -1 and 5 points	1 hour
Secondary	Percentage of glottis opening (POGO)	Grading of the best view obtained during laryngoscopy (%)	1 hour
Secondary	Impossible facemask ventilation	Observed impossible facemask ventilation after induction of anesthesia	1 hour
Secondary	Successful first attempt intubation	Observed during airway management	1 hour
Secondary	Airway-related adverse events	Laryngospasm, bronchospasm, larynx trauma, airway trauma, soft tissue trauma, oral bleeding, edema, dental damage, corticosteroid application, accidental esophageal intubation, aspiration, hypotension or hypoxia	1 hour
Secondary	Post-intubation recommendation for an intubation method	Recommendation of the responsible anaesthesiologist after airwaymanagement	1 hour
Secondary	Minimal peripheral oxygen saturation (SpO2)	Observed after induction of anesthesia	1 hour